Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee (Artico)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Eurofarma Laboratorios S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT00955552
First received: August 5, 2009
Last updated: March 3, 2010
Last verified: August 2009
  Purpose

The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Glucosamine sulphate and chondroitin sulphate association
Drug: Condroflex (Zodiac)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Condroflex (Zodiac) to Patients Treatment With Osteoarthrosis of the Knee Study

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Condroflex® (Zodiac) in same presentation and pharmaceutical form [ Time Frame: approximately 5 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Condroflex Drug: Condroflex (Zodiac)
oral capsule of glucosamine sulphate 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
Other Names:
  • Condroflex
  • glucosamine sulphate and chondroitin sulphate
Experimental: Glucosamine/chondroitin sulphate
Glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal
Drug: Glucosamine sulphate and chondroitin sulphate association
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
Other Names:
  • Artico Capsulas
  • Glucosamine sulphate and Chondroitin sulphate

Detailed Description:

To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Condroflex® (Zodiac) in same presentation and pharmaceutical form.

Some eligibility criteria:

Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) > 40 mm; Clinical diagnosis of pain and functional limitation

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study.
  • Male or female Subjects, aged upper to 40 years.
  • Osteoarthritis of the knee confirmed by radiological examination.
  • Visual analogue scale (VAS) > 40 mm.
  • Kellgren and Lawrence grade 1 to 3.
  • Clinical diagnosis of pain and functional limitation.

Exclusion Criteria:

  • History of significant trauma or surgery in the affected joint.
  • Pregnant women, lactating or not using appropriate contraceptive method.
  • History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis.
  • Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation <40mm/h and rheumatoid factor <1:40).
  • Body mass index > 30.
  • Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria).
  • Systemic administration and/or intra-articular corticosteroids in the last 3 months.
  • Have made use of glucosamine and/or chondroitin.
  • Lequesne index of > 12.
  • Arthroplasty in the affected joint.
  • Use of narcotic analgesics.
  • Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955552

Contacts
Contact: Carine M. Sanches, Coordinator +55 11 5090 8727 carine.martins@eurofarma.com.br

Locations
Brazil
Instituto de Pesquisa Clínica e Assistencia Medica de Campinas Not yet recruiting
Campinas, Sao Paulo, Brazil, 13073-350
Contact: Jose A. Mendonca, Phd/MD    +55 19 3242 4077    mendoncaja@ig.com.br   
Principal Investigator: Jose A. Mendonca, Phd/MD         
Irmandade da Santa Casa de Misericordia de Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 01221-010
Contact: Branca B. Souza, Phd/MD    +55 11 2176 7281    Branca_souza@hotmail.com   
Principal Investigator: Branca B. Souza, Phd/MD         
Instituto de Medicina Avancada Not yet recruiting
Sao Paulo, Brazil, 05437-000
Contact: Marise L. Castro, PHd/MD    +55 11 3863 9156    marise.lazaretti@imabrasil.com.br   
Principal Investigator: Marise L. Castro, Phd/MD         
Centro Paulista de Investigacoes Clinicas Ltda Not yet recruiting
Sao Paulo, Brazil, 04266-010
Contact: Cristiano F. Zerbini, Phd/MD    +55 11 2915 8325    criszerb@uol.com.br   
Principal Investigator: Cristiano F. Zerbini, Phd/MD         
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
Principal Investigator: Branca B. Souza, Phd/MD Irmandade da Santa Casa de Misericordia de Sao Paulo
Principal Investigator: Marise L. Castro, Phd/MD Instituto de Medicina Avancada
Principal Investigator: Cristiano F. Zerbini, Phd/MD Centro Paulista de Investigacoes Clínicas Ltda.
Principal Investigator: Jose A. Mendonça, Phd/MD Instituo de Pesquisa Clínica e Assistencia Medica de Campinas
  More Information

No publications provided

Responsible Party: Carine Martins Sanches, Eurofarma Laboratorios Ltda
ClinicalTrials.gov Identifier: NCT00955552     History of Changes
Other Study ID Numbers: EF-093
Study First Received: August 5, 2009
Last Updated: March 3, 2010
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
osteoarthritis (OA)
knee

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 18, 2014